Kornimate/medical-research-clean huggingface dataset:
a study on safety and preliminary efficacy of ala in acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ala used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.


Eligibility criteria:
inclusion criteria: 1. chinese male or female patients aged 18 - 40 years; 2. grade iii-iv facial acne vulgaris according to the pillsbury international improvement scale.; 3. all patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan; 4. informed consents were signed. exclusion criteria: 1. suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases; 2. obviously abnormal liver and kidney function; 3. suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen); 4. secondary acne patients, such as occupational acne or acne caused by corticosteroids; 5. complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc; 6. other diseases that may significantly affect the efficacy evaluation; 7. pregnancy, lactation patients; 8. exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months); 9. exposed to systemic antibiotics, glucocorticoids, spironolactone and other drugs for treating acne 4 weeks prior to the study; physical therapy for the treatment of acne; 10. exposed to topical retinoids on the face 4 weeks prior to the study or topical antibiotics, glucocorticoids, and other topical treatment 2 weeks prior to the study; 11. participated in other clinical trials 3 months prior to the study; 12. other reasons that the investigator considered inappropriate for participation in the study.
a human monoclonal antibody against staphylococcus aureus alpha toxin in mechanically ventilated adult subjects - 2

Conditions: Ventilator Associated Pneumonia; Staphylococcus Aureus

Summary: clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by staphylococcus aureus in high-risk patients

this is a phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy of a single iv dose of suvratoxumab in mechanically ventilated subjects in the icu who are at high risk for s. aureus infections and who are currently free of active s. aureus-related disease but are colonized with s. aureus in the lrt.

Eligibility criteria:
inclusion criteria: 1. colonized with staphylococcus aureus; 2. expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. exclusion criteria: 1. staphylococcal disease at randomisation; 2. lung injury score consistent with pneumonia; 3. chronic tracheostomy patients; 4. the study subject is moribund 5. receipt of anti- s. aureus systemic antibiotics 6. active pulmonary disease
masticatory efficiency in children

Conditions: Mastication Disorder

Summary: this study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. also, to assess the correlation between masticatory efficiency and nutritional status. the study will be conducted on children between 3 and 14 years of age. masticatory efficiency will be evaluated by the optical scanning method. participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. by scanning the comminuted particles, data on each particle's size will be obtained. enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.


Eligibility criteria:
inclusion criteria: * children of both genders aged 3 to 14, with: * full healthy dentition * bilateral dental caries stage 4,5 or 6 by icdas criteria * reduced number of occlusal contacts * dentures * signed informed consent by participant's parents * verbal consent of the children exclusion criteria: * uncooperative behavior * symptoms of temporomandibular joint dysfunction * parafunctional habits * systemic disturbances that can impact mastication * ingestion of medicines that could interfere directly or indirectly with muscular activity * tooth anomalies of structure, number or form * periodontal disease * tooth mobility

Keywords: body mass index child mastication stomatognathic diseases particle size
measuring cell free dna during the course of treatment for esophageal cancer as a marker of response and recurrence

Conditions: Esophageal Neoplasm; Esophageal Neoplasms Malignancy Unspecified; Esophageal Neoplasms Malignant; Cancer of Esophagus; Cancer of the Esophagus; Esophageal Cancer; Esophagus Cancer; Neoplasm, Esophageal

Summary: to prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free dna) during the course of treatment as a marker of response and recurrence.

esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. while survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. however, quantifying cfdna is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer. to identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. from this data, the investigators will select 10-15 genes to focus their efforts. pcr primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer. the investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Eligibility criteria:
inclusion criteria: * esophageal cancer any stage * age \>18 years old * willing and able to provide consent * no prior history of neoadjuvant therapy for the esophageal cancer exclusion criteria: * age \<18 years old * unable to provide consent
bioactive milk peptides and blood pressure

Conditions: Stage 1 Hypertension

Summary: the purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.


Eligibility criteria:
inclusion criteria: * age 30-60 years * systolic blood pressure 140-160 mmhg and diastolic blood pressure 90-99 mmhg in office measurement * apparently healthy exclusion criteria: * antihypertensive and lipid-lowering drugs * unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension * bmi \> 32 kg/m2 * milk allergy * smoking * alcohol abuse * pregnancy, lactation * simultaneous participation in other clinical trial

Keywords: hypertension blood pressure milk peptides bioactive peptides randomized controlled trial
effects of esketamine at subanesthetic dose on emergence delirium in preschool children undergoing ambulatory laparoscopic surgery

Conditions: Inguinal Hernia

Summary: emergence delirium (ed) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. the incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. the goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ed.


Eligibility criteria:
inclusion criteria: 1. laparoscopic inguinal hernia repair under general anesthesia 2. aged 24\~71 months 3. american society of anesthesiologists physical status i or ii 4. body mass index for age between the 5th and 85th percentiles exclusion criteria: 1. allergy to esketamine 2. abnormal liver or kidney function 3. glaucoma or neurological disorders 4. cardiovascular or endocrine dysfunction 5. asthma or respiratory infection in the last 2 weeks 6. developmental delay
examination of microcirculation of the caput humeri after proximal humerus fracture

Conditions: Proximal Humeral Fractures

Summary: this study examines the microcirculation of the caput humeri after proximal humeral fracturation using o2c light probes. during the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. the o2c light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. the data is analysed in respect to the fracture type according to the classification of neer. valuable additional information for the correct treatment and prognosis of humeral fractures is expected.


Eligibility criteria:
inclusion criteria: * traumatic fractures of the proximal humerus * surgical treatment * over eighteen years of age exclusion criteria: * pathological fractures * conservative treatment * soft tissue damage * delay of surgery more than three days * immunological defects * multiple trauma

Keywords: microcirculation proximal humeral fractures o2c
quantification of exhaled particles to identify airborne transmission risks of covid-19

Conditions: Healthy

Summary: in this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. the differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.


Eligibility criteria:
inclusion criteria: 1. able and willing to give written informed consent. 2. healthy male and female subjects, aged 18-80 years. 3. body mass index between 18 and 35 kg/m2. 4. fev1 ≥ 80% predicted. exclusion criteria: 1. any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. 2. risk of non-compliance with study procedures. 3. suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. 4. history of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. in case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. subjects must be asymptomatic for at least 3 days. re-screening is allowed should the time window be exceeded. 5. history of lung disease including but not confined to copd, asthma or pulmonary fibrosis. 6. history of latex allergy.

Keywords: aerosols exhaled particles face mask
a randomised trial of artekin and artesunate & amodiaquine for uncomplicated malaria in timika, papua, indonesia.

Conditions: Malaria, Falciparum; Malaria, Vivax

Summary: the primary aim of the comparative trial is to assess the relative safety and efficacy of two artemisinin containing regimens: amodiaquine plus artesunate (aaq) and artekin both administered once daily for 3 days.

with the emergence of species of multi drug resistant p.falciparum across the archipelago the indonesian centre for disease control (cdc) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of p. falciparum. high levels of chloroquine resistance to p.vivax has also emerged in the eastern provinces. this trial sets out to assess the efficacy of artekin and amodiaquine plus artesunate and artekin against both p.falciparum and p. vivax. and their safety profiles. patients who present to an established rural outpatient clinic in timika, papua with symptoms of acute, uncomplicated infection with p. falciparum, p.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic. the data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the timika region. in order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).

Eligibility criteria:
inclusion criteria: * male and female patients at least one 1year of age and weighing more than 5kg. * microscopic confirmation of p. falciparum and /or p.vivax infection (any parasitaemia). * fever (axillary temperature \>37.5oc) or history of fever in the last 48 hours. * able to participate in the trial and comply with the clinical trial protocol * written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent exclusion criteria: * pregnancy or lactation * inability to tolerate oral treatment * signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment * known hypersensitivity or allergy to artemisinin derivatives * serious underlying disease (cardiac, renal or hepatic) * parasitaemia \>4%

Keywords: falciparum vivax papua amodiaquine artekin artemisinin combination therapy dihydroartemisinin piperaquine lumefantrine artemether
obesity treatment in a managed care setting

Conditions: Obesity; Weight Loss

Summary: the aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. primary outcomes are participation rates in programs, weight change, and cost.


Eligibility criteria:
* at least 18 years of age * bmi ≥ 27.8 kg/m2 for men * bmi ≥ 27.3 kg/m2 for non-pregnant or lactating women

Keywords: obesity treatment weight management managed care
daxor - blood volume analysis

Conditions: Heart Failure; Congestive Heart Failure

Summary: the purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

the purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. blood volume analysis (bva) measures how much blood is in the investigator's arteries and veins and is performed by using an iv and injecting a small amount of a radioactive material (i 131-labeled albumin). the study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). there will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.

Eligibility criteria:
inclusion criteria: - admission for acute decompensated heart failure to the cardiology service at duke hospital, durham, north carolina exclusion criteria: * age \< 18 years * ongoing pregnancy * recent acute mi or hemodynamic instability: acute mi (stemi or type i nstemi) within 7 days * post heart transplantation or ongoing mechanical circulatory support * progressive cardiogenic shock * patients with ventricular assist devices * end stage renal disease
intermediate cervical block under ultrasound for thyroid surgery: impact on per and postoperative opioid consumption

Conditions: Local Anesthesia; Analgesia Disorder

Summary: the investigators included prospectively 35 patients undergoing an intermediate cervical block under ultrasound (gp1) before a thyroidectomy ,compared to a group of 35 patients without a block (gp2).

the investigators performed prospective trial with 70 patients randomized in two groups each of 35: * group 1 (gp1): bilateral echo-guided intermediate cervical plexus bloc (icb) by 10 ml of isobaric bupivacaine (0.25%). * group 2 (gp2): control. ten minutes after icb, general anesthesia was realised. total dose of remifentanil is calculated upon awakening, the postoperative pain is determined by visual analog scale from 0 to 10 (vas) statements to h0, h2, h4, h6, h12 and h24. whenever vas is greater than or equal to 4, a morphine titration was administered. total dose consumption, side effects and satisfaction are noted at the end of protocol.

Eligibility criteria:
inclusion criteria: * candidate for thyroidectomy * reoperation l exclusion criteria: * no consent * bmi\> 34 * allergy to any of the products used * reoperation

Keywords: cervical plexus block thyroidectomy opioid consumption
study evaluating novel biomarkers of aki (acute kidney injury) in post-operative patients

Conditions: Acute Kidney Injury; Arterial Hypertension; Obesity; Cardio Vascular Disease; Diabetes Mellitus; Chronic Liver Disease; Hypercholesterolemia

Summary: to validate the use of \[timp-2\]●\[igfbp-7\] to predict aki in patients undergoing major intra abdominal surgery.

a prospective pilot single center study to investigate the potential of \[timp-2\].\[igfbp-7\] to predict aki (acute kidney injury) in patients undergoing major abdominal surgery. the investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on pacu (post anesthesia care unit).the primary endpoint of this study is the development of aki stage 2 or 3 within the first 72 postoperative hours.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * high risk patients: general surgery aki risk index class iii, iv or v * major abdominal surgery exclusion criteria: * ongoing acute kidney injury stage 2/3 * history of kidney transplant

Keywords: biomarker intra abdominal surgery aki
phase 2 trial using rhdnase to reduce mortality in covid-19 patients with respiratory failure

Conditions: Covid19

Summary: this phase 2 randomized placebo controlled trial will determine if administering nebulized dornase alpha (rhdnase) to covid-19 patients with respiratory failure is safe and will reduce 28-day mortality.


Eligibility criteria:
inclusion criteria: 1. male or female age 18 or older 2. on high flow oxygen =/\> 6 liters nasal cannula (or) 3. on mechanical ventilation 4. clinical diagnosis of covid-19 \& positive pcr test (or) 5. clinical diagnosis of covid-19 \& negative pcr test with clinical symptoms of covid-19 and pathognomonic lesions on a chest ct scan exclusion criteria: 1. known allergy to pulmozyme 2. less than 18 years of age 3. grave condition with anticipated death within 48 hours; at the discretion of treating physician. 4. enrollment in another clinical trial receiving investigatory drugs

Keywords: covid-19, coronavirus
comparing intrathecal morphine with erector spina plane block in open gastrectomy surgery

Conditions: Opioid Use; Post Operative Pain; Pain Assessment Scales

Summary: open gastrectomy causes severe postoperative pain due to wide surgical incisions, retraction of the abdominal wall and direct manipulation of the visceral organs. it leads to delayed postoperative recovery, increased medical expenses and poor surgical outcomes. epidural analgesia, intrathecal morphine and patient-controlled analgesia are frequently used in the postoperative pain management of abdominal surgeries. intrathecal morphine is applied as a standard protocol in many centers due to its ease of application and effective pain control. however; it has undesirable effects such as postoperative nausea-vomiting, itching and most importantly respiratory depression. regional interfascial plane blocks, such as erector spina plane block, have recently been popular in clinical practice to provide postoperative pain control. erector spina plane block, when placed preoperatively, is expected to reduce opioid consumption and improve outcomes. the primary implication of this study is to compare postoperative pain scores and opioid consumption. it is also aimed to compare the effectiveness of numeric rating scale and clinically aligned pain assessment tool used in postoperative pain assesment.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients undergoing open gastrectomy surgery exclusion criteria: * patients with solid organ dysfunction * patients who receive opioid or corticosteroid medication prior to surgery * patients with bleeding diathesis * patients with psychiatric disorders * patients who can not be contacted after surgery

Keywords: erector spina plane block intrathecal morphine
safety and efficacy of dlbs1033 in healthy subjects

Conditions: Healthy

Summary: the objective of this study are: 1. to evaluate the safety of dlbs1033 in comparison with placebo in healthy adult subject 2. to evaluate the efficacy of dlbs1033 in comparison with placebo in healthy adult subject

this study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a fixed dose regimen. the study will involve twenty (20) healthy subjects. the study will be a comparative study of safety and efficacy of dlbs1033 with placebo. each study period will consist of 14 days treatment with a 2-week wash-out period in between. the evaluation of safety parameters will be performed at day 1 (baseline), 7, and 14; while the efficacy parameters will be performed at day 1, 2, 7, and 14.

Eligibility criteria:
inclusion criteria: * male or female 18 - 50 year-old at screening * having good and stable health judged on the basis of medical history, physical examination, and routine laboratory * able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study exclusion criteria: * participating in other clinical trial within 4 weeks prior to screening * had a major surgical procedure or dental procedure within 4 weeks prior to screening * history of any of the following medical conditions: haemophilia, past medical history of haemorrhagic stroke, acid peptic disease, easy bruising and frequent external bleeding * any other known current medical condition, which is judged by the investigator could jeopardize subject's health or interfere with the study evaluation * being on regular medication(s), including traditional medicine(s) * pregnant or lactating women (urinary pregnancy test will be applied to women subjects during screening and just before treatment in each periods)

Keywords: dlbs1033 safety fibrinolytic fibrinogenolytic antiplatelet